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Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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Director, CMC Regulatory Affairs – Biologics. Head of CMC Regulatory Affairs – Small Molecules. Associate Director, Regulatory Affairs Advertising and Promotion page is loaded.
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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
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Similar Jobs (5) Director, Regulatory CMC, Cell & Gene Therapy (Boston) locations Boston, MA time type Full time posted on Posted 4 Days Ago External Manufacturing Associate Director (Person In Plant) - Cell & Gene Therapy locations Boston, MA time type Full time posted on Posted 30+ Days Ago Supply Chain Manager - Cell & Gene Therapy (Hybrid) locations Boston, MA time type Full time posted on Posted 25 Days Ago.
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Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product.
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Associate Director/Associate Principal Scientist - Regulatory Affairs International Chemistry Manufacturing & Controls. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance submissions, original registrations, and post-approval changes.
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Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC. A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC.
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This position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Minimum of 8 years of pharmaceutical/biotech experience, including 5 years of Global Regulatory Affairs (CMC) experience. They are seeking an Associate Director, Global Regulatory CMC, to develop and execute global regulatory strategies for assigned programs.
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Represent PCDS at team meetings and coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences. The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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The position requires sustained, concise communication with departmental team leaders, project managers, Quality Assurance, and CMC Regulatory Affairs so a firm command of the English language as well as excellent verbal and written communication skills, and a knowledge of computer applications and data acquisition systems are essential.
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Provide strategic guidance to project teams and senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy. Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is required as is a background in the safety assessment of drugs intended to treat diseases of the hepatic, kidney, muscular and central nervous systems.
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Associate Director/Director of Regulatory Affairs, CMC & Regulatory Sciences will be responsible for providing regulatory guidance to (Bio)Pharma product development, especially biosimilars, preparing and reviewing submissions.
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